FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
52959-131
11-digit product format
529590131
Labeler code
52959
Product ID
52959-131_85ad079e-088c-493d-bd2a-deaa107391bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077712
Marketing category
ANDA
Marketing start
2009-03-02
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-131-022019-11-13C16284748780-197449f38-d283-f6ea-e053-dbdaa90aa703OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 15 mg, and 30 mg CII Rx only
52959-131-302019-11-13C16284748780-197449f38-d283-f6ea-e053-dbdaa90aa703OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 15 mg, and 30 mg CII Rx only
52959-131-502019-11-13C16284748780-197449f38-d283-f6ea-e053-dbdaa90aa703OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 15 mg, and 30 mg CII Rx only
52959-131-602019-11-13C16284748780-197449f38-d283-f6ea-e053-dbdaa90aa703OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 15 mg, and 30 mg CII Rx only
52959-131-902019-11-13C16284748780-197449f38-d283-f6ea-e053-dbdaa90aa703OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 15 mg, and 30 mg CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-131-02Oxycodone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
52959-131-30Oxycodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
52959-131-50Oxycodone Hydrochloride50 in 1 BOTTLE, PLASTICTABLET502
52959-131-60Oxycodone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
52959-131-90Oxycodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-131-02EA - Each52959-131418a7d2d-4c4d-48ed-bf0a-d6acc38a7ef412012-07-24
52959-131-30EA - Each52959-131ae6c5337-4340-4313-9efb-159a7da1969012012-07-24
52959-131-50EA - Each52959-1312825064a-66bc-4bb0-ad33-7ef31fd47e1212012-07-24
52959-131-60EA - Each52959-131590a05fb-5f12-40b1-87a3-0ce22f9033bf12012-07-24
52959-131-90EA - Each52959-13140d22b88-5200-470f-bc3e-e331554fd00a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-131OXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 5 package rows20111216_3efb2cf8-9b0e-4d76-afb1-c4ecd514d534.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049621oxyCODONE HCl 5 MG Oral TabletPSN3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049611oxycodone hydrochloride 15 MG Oral TabletSCD3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049621oxycodone hydrochloride 5 MG Oral TabletSCD3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-131-0252959013102120 in 1 BOTTLE, PLASTICHistorical
52959-131-305295901313030 in 1 BOTTLE, PLASTICHistorical
52959-131-505295901315050 in 1 BOTTLE, PLASTICHistorical
52959-131-605295901316060 in 1 BOTTLE, PLASTICHistorical
52959-131-905295901319090 in 1 BOTTLE, PLASTICHistorical